BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX CA-1500

    MDR report key: 3137026 · Received May 28, 2013

    Report

    Report Number
    3009711478-2013-00008
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKP
    PMA / PMN Number
    K993299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVIDENCE OF PRODUCT MALFUNCTION WAS PROVIDED (ERROR LOG OR OTHER). THE ANALYZER WAS NOT IN USE AT THE TIME. SIEMENS DID NOT NOTE IF FIELD SERVICE EXAMINED THE ANALYZER AFTER THE EVENT. THE SYSMEX CA-1500 INSTRUCTIONS FOR USE INCLUDES NUMEROUS WARNINGS REGARDING SAFE HANDLING OF THE SAMPLE PROBE AND CAP PIERCER. A USER IS ADVISED TO HANDLE ALL INSTRUMENT PARTS AS BIOLOGICALLY HAZARDOUS, TO WEAR GLOVES WHILE HANDLING THE PROBES AND TO WASH HANDS WITH DISINFECTANT AFTER CLEANING. WHEN CLEANING, THE PROBE IS TO BE HANDLED FROM TOP TO BOTTOM TO PREVENT PIERCING A FINGER. A USER ALSO IS WARNED THAT THE PIERCER IS EXTREMELY SHARP AND, IF MISHANDLED, COULD CAUSE INJURY. CURRENT STATUS OF THE USER IS NOT KNOWN. THIS OCCURRENCE IS REPORTED IN CONSIDERATION OF THE FDA NEEDLE - STICK GUIDANCE, AS ANTI-VIRAL POST-EXPOSURE PROPHYLAXIS MAY HAVE BEEN ADMINISTERED IN ADDITION TO FIRST AID. THE NARRATIVE PROVIDED DOES NOT STATE THAT THE DEVICE FAILED IN ANY WAY. ANY OTHER CORRECTIVE ACTION PERFORMED ON THE ANALYZER, OTHER THAN CLOG REMOVAL, IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    (B)(4) REPORTED TO SYSMEX CORPORATION, (B)(4) ON (B)(6) 2013 AN INCIDENT OF POSSIBLE EXPOSURE BY A USER ATTEMPTING TO CLEAR A CLOG IN THE CAP PIERCER ON THE SAMPLE PROBE OF A CA-1500 AUTOMATED BLOOD COAGULATION ANALYZER WITH CAP PIERCER (SERIAL NUMBER (B)(4), INSTALLED ON 02/02/2010, LAST SERVICED ON (B)(4) 2013). THE EVENT OCCURRED IN (B)(6) AND WAS REPORTED TO (B)(4) ON (B)(6) 2013; (B)(4) REPORTED TO SYSMEX AMERICA, INC. ON (B)(6) 2013. FEW DETAILS WERE PROVIDED. THE USER, AS REPORTED, PRICKED HER HAND WITH THE CAP PIERCER WHEN TRYING TO UNCLOG THE PROBE. NO EVIDENCE OF PRODUCT MALFUNCTION WAS PROVIDED. THE USER WAS NOT WEARING GLOVES AT THE TIME OF THE EVENT, WHICH OCCURRED ON THE NIGHT SHIFT. THE USER DID NOT PROVIDE DETAILS TO HER SUPERVISOR. A DOCTOR (ROLE, TITLE UNKNOWN) CONTACTED THE USER. INITIALLY, SHE STATED THAT SHE WAS NOT WORRIED, BUT THEN CHANGED HER MIND AND SOUGHT MEDICAL ATTENTION. THE DOCTOR FOLLOWED UP WITH HER; SHE IS WORKING AND FEELING FINE, BUT DOES NOT KNOW ANYTHING ABOUT HER ANALYTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233350 SYSMEX CA-1500 AUTOMATED COAGULATION ANALYZER GKP SYSMEX CORPORATION CA-1500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other